Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
8. Nanocrystalline Silver Gel 0.002% 08-01-08
For the treatment of burns and wound infections
113. Silver wound dressing 16-04-08
As an antimicrobial barrier for management
of partial thickness burns, incisions, skin grafts,
donor sites, lacerations. abarations and
Stage I-IV dermal ulcers, (vascular, venous, pressure and diabetic )
U.S.FDA APPROVED DRUGS DURING 2004
248. FDC of Epi-Growth Factor (1gm)+ 19-10-2004
Silversulphadiazine Cream For Burns
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.FDC of EPI-Growth Factor 1gm + 19-10-2004
Silver sulphadiazine cream
For Burns
2.Nonocrystalline Silver gel 04-01-2008
0.002%
For the treament of Burns and wound infections
3.Silver wound Dressing 16-04-2008
As an Antimicrobial Barrier for Management of Partial Thickness Burns,
Incisions, Skin Grafts, Donor Sites, Lacerations, Abarations and
Stage-1-IV Dermal ulcers( Vascular Venous, Pressure and Diabetic)
Patient Information:
1.Apply under sterile conditions once or twice daily to a thickness of approx.
1/16 inch to the clean and debrided wound
2.Cover the burn areas with silver sulfadizine at all times
3. Whenever necessary reapply the cream to the areas from which it has been removed
by patient activity
4. Reapply immediately after hydrotherapy
5. Dressing are not required , but may be used if individual patient requirement
makes them necessary
Ref - USP PDI Vol II 17th Edition (1997)
SILVER SULPHADIAZINE - TOPICAL
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
silver sulfadiazine or any of the following. Also tell your healthcare care
professional if you are allergic to any other substances such as foods,
preservatives or dyes.
Acetazolamide
Antidiabeics
Diclorphenamide
Furosemide
Methozolamide
Sulfonamide
Thiazide diuretics
2.Pregnancy-
Studies have not been done in humans. However, sulfa medicine may increase
the chance of liver problems in new born infants. Silver Sulfadiazine has not
shown to cause birth defects or other problems in rabbits treated with 3 to 10 times
the usual amount of silver sulfadiazine.
3. Breast-feeding-
It is not known whether silver sulfadiazine applied to the skin and/or burns
passes into breast milk. However, caution is recommended when using this
medicine in nursing women.
4.Children-
Use is not recommended in premature or new born infants up to 1 month of
age. Although there is no specific information comparing use of silver
sulfadiazine in children with use in other age groups, this medicine
is not expected to cause different side effects or problems than it does
in adults.
5.Older adults-
There is no specific information comparing use of silver sulfadizine
in the elderly with use in other age groups.
6. Other medicines-
Tell your doctor if you are using any of the following medicines -
Collagensase or
Papain or
Sutilains - silver sulfadizine may prevent these enzymes from working
properly
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Blood problems or
Glucose -6-phosphate dehydrogenase deficiency- (G6PD enzyme)-
use of this medicine may cause blood problems or make them worse.
Kidney disease or
Liver disease - in persons with these conditions use may result
in higher blood levels of this medicine, a smaller dose may be
needed
Porphyria- Use of this medicine may result in a severe attack of
porphyria
Manufacturer Details